Hypogonadism MedDRA version: 20.0 Level: LLT Classification code 10043335 Term: Testicular hypogonadism System Organ Class: 100000004860
Conditions
Interventions
Trade Name: Testogel 50 mg, gel in sachet
Pharmaceutical Form: Gel in sachet
INN or Proposed INN: TESTOSTERONE
Other descriptive name: Testogel
Concentration unit: mg/g milligram(s)/gram
Concentration
Sponsors
Lars møller Pedersen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Age 18-65 years at inclusion Male Verified diagnosis of de novo DLBCL or classical HL diagnosed between april 2013 and april 2018 according to WHO classification. Disease in complete remission for at least 2 years at inclusion. Completed curative intent first line treatment with anthracycline-containing chemotherapy with or without consolidating radiotherapy Literate in Danish Serum testosterone level below age-adjusted reference level. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Concurrent low-grade lymphoma Current or prior lymphoma of the central nervous system (CNS) Current or prior lymohoma of the testes Verified prostate cancer, cancer of the mammae, primary liver cancer-related, polycythaemia vera Mental or physical conditions that are expected to prevent the necessary "compliance" and/or "adherence" in relation to the study procedures Contraindications for the treatment with testosterone: PSA > 3 ng/ml, Hct > 0,49 Treatment with second line chemotherapy or high dose therapy. Current or prior anabolic steroid abuse Known sexual dysfunction prior to enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The approach to surveillance and treatment of gonadal dysfunction following remission with first line therapy for malignant lymphoma remains controversial. With a paucity of evidence whether follow-up programs and treatment are effective, evidence-based guidelines for follow-up and treatment of gonadal dysfunction are needed. The main purpose of the current study is to assess the extent of sexual dysfunction, quality of life (QoL) and reduced levels of testosterone in male patients with Hodgkin lymphoma (HL) and diffuse large B-cell lymphoma (DLBCL). Furthermore, in a prospective phase 2 study, to test the impact on QoL before and after substitution with testosterone in patients with reduced levels of testosterone.;Secondary Objective: Not applicable;Primary end point(s): Effect of treatment with testosterone (Testogel) on QLQ C30 score.;Timepoint(s) of evaluation of this end point: At baseline, after 1,3,6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effect of treatment with testosterone on SHQ-C22 score. Effect of treatment with testosterone on IIEF-5 score S-testosterone Testosterone dose needed ;Timepoint(s) of evaluation of this end point: At baseline and after 1,3,6 and 12 months. | — |
Countries
Denmark
Contacts
Public ContactDepartment of hematology
Herlev Hospital
Outcome results
None listed